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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. PATIENT CABLE; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INC

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MEDTRONIC, INC. PATIENT CABLE; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INC Back to Search Results
Model Number 5487L
Device Problems Failure to Capture (1081); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2022
Event Type  malfunction  
Event Description
It was reported that the pacing cable was connected to the lead and was unable to capture, the cable was replaced but the issue was unresolved.The cables were replaced with an alternative model and the lead was then captured.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
PATIENT CABLE
Type of Device
CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INC
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key14468900
MDR Text Key292356173
Report Number2182208-2022-01665
Device Sequence Number1
Product Code DSA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960446
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 05/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5487L
Device Catalogue Number5487L
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/12/2022
Initial Date FDA Received05/23/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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